Disposable, single-use thermal exchange component

ABSTRACT

A disposable housing including a single-use thermal exchange component can be configured to be mechanically, removably coupled to a receptacle on a cuff positionable around a joint to provide temperature-based therapy to the joint.

CLAIM OF PRIORITY

This application is a continuation of commonly assigned Sham et al. U.S.patent application Ser. No. 12/882,878, entitled “DISPOSABLE, SINGLE-USETHERMAL EXCHANGE COMPONENT,” filed Sep. 15, 2010, which is acontinuation of commonly assigned Sham et al. U.S. patent applicationSer. No. 12/831,779, entitled “ELECTROMAGNETIC THERMAL THERAPY,” filedon Jul. 7, 2010, which is a continuation-in-part of commonly assignedGill et al. U.S. Pat. No. 7,783,348, entitled “STIMULATION DEVICE FORTREATING OSTEOARTHRITIS,” filed on Apr. 16, 2008, which claims priorityto Gill et al. U.S. Patent Application Serial No. 60/927,354, entitled“STIMULATION DEVICE FOR TREATING OSTEOARTHRITIS,” filed on May 3, 2007,and to Gill et al. U.S. Patent Application Serial No. 60/983,653,entitled “STIMULATION DEVICE FOR TREATING OSTEOARTHRITIS,” filed on Oct.30, 2007, the benefit of priority of each of which is claimed hereby,and each of which are incorporated by reference herein in its entirety.

BACKGROUND

Osteoarthritis, also known as degenerative joint disease, ischaracterized by gradual loss of hyaline cartilage and, in extremecases, cyst formation in and deformation of the subchondral bone. Thehyaline cartilage lines the articular surfaces of the knee and providescushion and lubrication for the joint. During osteoarthritis, theextra-cellular matrix of the cartilage is worn down at a greater ratethan it is being synthesized, leading to a net reduction in the overallamount of cartilage at the articular surfaces of the knee. As thecartilage breaks down, symptoms such as pain, swelling, tenderness,stiffness, and eventual muscle atrophy are manifested. Chondrocytes, thecellular component of hyaline cartilage that is responsible for matrixsynthesis and turnover, are also depleted, thus resulting in aninability to naturally recover from this disease. Additionally, cellspresent in osteoarthritic joints release catabolic cytokines and enzymesthat suppress collagen synthesis.

To date, conventional therapies for osteoarthritis have aimed atreducing pain and the progression of joint damage in order to minimizedisability and maximize quality of life. The current algorithm for themanagement of osteoarthritis includes diagnosing the disease, modifyingpatient activity, prescribing anti-inflammatory medications, injectingsteroids into the knee, and as a last resort, surgery. Although thisregimen does provide some benefit, it is by no means a cure all forpatients with osteoarthritis.

Aside from the conventional therapies, there are currently a number ofalternative therapies that may be used to treat osteoarthritis. Three ofthe forerunners in the non-invasive alternative therapy field includeelectric, static magnetic, and electromagnetic stimulation.

Electrical stimulation, such as transcutaneous electrical nervestimulation (TENS), delivers mild electrical impulses across the skinand into regional nerves. In patients having osteoarthritis, painimpulses are transmitted to the spinal cord through small cutaneousfibers. TENS acts to stimulate large cutaneous fibers that subsequentlytransmit a faster impulse via C-fibers to inhibit pain signals from thesmall fibers. It is in this way that TENS masks the pain normallyexperienced by patients having osteoarthritis. It is also thought thatTENS incites the secretion of endogenous opiates, the body's naturalpain killers, further reducing the pain experienced by patients withosteoarthritis.

Static magnetic stimulation has also been shown to provide medicallyrelevant benefits. Various experiments designed to induce osteoporosis,fracture, and synovitis in animals have demonstrated faster bone repair,increased bone density, and decreased joint inflammation followingmagnetic treatments. It is thought that magnets can affect biologicalprocesses by: decreasing the firing rate of chronic pain neurons;modifying the rate of enzyme-mediated reactions; modulatingintracellular signaling by affecting the functioning of calcium channelsin the cell membranes; and enhancing blood flow. All of the above mayprovide some therapeutic benefit with respect to the symptoms ofosteoarthritis.

Additionally, electromagnetic stimulation, a modality that generates amagnetic field by sending current through a coil, may also providemedical benefits for the treatment of osteoarthritis. It has beenobserved that physical stress on bone causes the appearance of tinyelectric currents (piezoelectric potentials) that are thought to be themechanism of transduction of the physical stresses into a signal thatpromotes bone formation. In particular, studies of electrical phenomenain cartilage have demonstrated a mechanical-electrical transductionmechanism resembling those described in bone, appearing when cartilageis mechanically compressed. Generating currents within cartilage isthought to stimulate chondrocyte activity, thus promoting the synthesisof cartilage. New cartilage synthesis may work to combat thedegeneration seen in osteoarthritis and therefore alleviate the symptomsof osteoarthritis.

Thus, there is a need for an improved device and method to treatosteoarthritis.

OVERVIEW

In various embodiments disclosed herein, devices or methods for thetreatment of osteoarthritis are disclosed. More particularly, certainembodiments relate to portable, disposable pulsed electromagnetic field(PEMF) stimulation and thermal therapy devices for treatingosteoarthritis and their methods of use.

A portable, non-invasive device comprised of a multiple usage cuff andtwo single-use therapy units is designed to provide Electro-MagneticThermal Therapy (EMT²) for treating knee osteoarthritis. The EMT²provides both transcutaneous pulsed electromagnetic field stimulationand thermal therapy. For purposes of this application, it is understoodthat “thermal therapy” means any therapy that provides for applicationof heat or cold for purposes of treatment. The EMT² is designed toalleviate pain and increase range of motion without requiring directskin contact to the afflicted joint. The single-use therapy units offerheat or cooling and PEMF stimulation when inserted into the cuff, whichprovides the power and control for the coils. The cuff may contain arechargeable power source capable of delivering a recommended amount oftherapy and the coils for delivering the PEMF stimulation. The cuff maybe fastened to the knee in a manner that directs the therapy to themedial and lateral areas of the joint. Furthermore, the cuff may bedesigned such that it is aesthetically pleasing and comfortable to wearduring daily activities either over or underneath clothing, therebyincreasing patient compliance.

The basic principle behind the concept of electromagnetic stimulation isthat passing an electric current through a coil winding structure willgenerate an electromagnetic field. The electromagnetic field can, inturn, generate a current in any conductive material, such as nerves orother body tissues, within this field. The electromagnetically inducedelectric field created by properly oriented pulsed electromagneticstimulation thus accomplishes the result of transferring charge to cellsof the body. This induced current can lead to nerve firing, musclecontraction, stimulation of cell signaling pathways causing cell growth,and a number of other effects. In contrast to applications of electricalstimulation, pulsed electromagnetic stimulation does not require directskin contact to induce nerve excitation. As a result, significantlyhigher levels of directed stimulation can be achieved through pulsedelectromagnetic stimulation without the adverse effects of othertechnologies.

Thus, the EMT² devices and methods disclosed herein are designed with apowerful electromagnetic stimulating means created for the purpose ofstimulating nerve, muscle, and/or other body tissues. Previous clinicalstudies have shown a high correlation between low-frequency PEMF and newcartilage growth for treating osteoarthritis. The inventive deviceprovides an easy-to-use, portable system that may have applicationswithin a host of clinical and home health applications.

This overview is intended to provide an overview of subject matter ofthe present patent application. It is not intended to provide anexclusive or exhaustive explanation of the invention. The detaileddescription is included to provide further information about the presentpatent application.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, which are not necessarily drawn to scale, like numeralsmay describe similar components in different views. Like numerals havingdifferent letter suffixes may represent different instances of similarcomponents. The drawings illustrate generally, by way of example, butnot by way of limitation, various embodiments discussed in the presentdocument.

FIG. 1 is a diagram illustrating a typical human knee joint model.

FIG. 2 is a block diagram illustrating a stimulation device for treatingosteoarthritis in the knee according to one embodiment.

FIG. 3 is a front view of one embodiment of a stimulation device that issecurable to a patient's knee for delivery of electromagnetic andthermal therapy.

FIGS. 4A and 4B illustrate the stimulation device of FIG. 3 secured tothe patient's knee.

FIG. 5 is an exploded perspective view of the stimulation device of FIG.3.

FIG. 6 is an enlarged exploded view of a portion of the stimulationdevice of

FIG. 3.

FIG. 7 is a perspective view of one embodiment of a stimulation devicein the form of a patch that is securable to a patient's body fordelivery of electromagnetic and thermal therapy.

FIG. 8 illustrates generally an exploded perspective view of an activeknee system.

FIG. 9 illustrates generally an example of an active ankle system.

FIG. 10 illustrates generally an example of an active back system.

FIG. 11 illustrates generally an example of an active elbow system.

FIGS. 12 and 13 illustrate generally examples of an active wrist system.

DETAILED DESCRIPTION

A device for providing therapeutic treatment to a body part such as ajoint to promote healing of the body part comprises a signal generatorfor generating a pulsed electromagnetic field based upon a selectedtreatment mode, a controller for storing the treatment mode andcommunicating the treatment mode to the signal generator, a heat sourceconfigured to provide thermal therapy to the body part, and monitoringmeans for monitoring the electromagnetic field generated by theelectromagnetic stimulating means. The device may also include telemetrymeans in communication with the monitoring means for remotely accessingthe controller to modify the treatment mode. The device can also bedisposable.

FIG. 1 is a diagram illustrating a typical human knee joint model. Asshown in FIG. 1, the typical human knee joint includes a compartmentfilled with synovial fluid that is bounded by articular cartilage on theends of the femur and tibia, respectively, and fibrous capsules. Inaccordance with one embodiment of the devices and methods discussedherein, osteoarthritis in the knee joint may be treated by theapplication of heat or cold and specific and selective electromagneticfields via coils positioned adjacent to the knee joint. As will bediscussed in more detail to follow, a signal generator means may providethe appropriate signals to the coils for generating the specific andselective electromagnetic fields. The specific and selectiveelectromagnetic field needed to treat osteoarthritis in the knee jointmay be calculated, and varies depending upon, among other factors, thedimensions of the tibia and femur and the severity of the symptoms.Furthermore, a heating or cooling source may also be positioned adjacentto the knee joint to relieve pain, reduce patient discomfort, andincrease range of motion. The heating or cooling source can also bereferred to as a “thermal exchange component,” which, for purposes ofthe instant application, means any component or device that can be usedto apply heat (or any temperature that is higher than the patient's bodytemperature or the ambient temperature) or cold (or any temperature thatis lower than the patient's body temperature or the ambienttemperature).

More particularly, the implementations discussed herein relate todevices and methods for generating both (1) heat or cold, and (2)selective pulsed electromagnetic fields for the treatment of diseasedtissue in a joint, such as a knee joint. The devices, which may bedesigned in numerous forms such as a knee brace or a small dermal patch,preferably offer transcutaneous stimulation for treating osteoarthritis.The devices may be designed to provide stimulation directly to theafflicted joint to alleviate pain and increase range of motion.

As will be discussed in further detail in subsequent paragraphs, thevarious EMT² stimulation device embodiments may be designed to attach toa patient for a prolonged period of time while having little disruptionto daily activities and minimal skin irritation. In addition, thestimulation devices may be designed such that it is aestheticallypleasing and comfortable to wear. As a result of these and other designcharacteristics, patient refusal of treatment due to discomfort (i.e.,patient “non-compliance”) may be minimized.

Pulsed electromagnetic fields generate small, induced currents (Faradaycurrents) in the highly conductive extracellular fluid, which therebymimics endogeneous electrical currents. The endogeneous electricalcurrents are due primarily to movement of fluid containing electrolytesin channels of the bone containing organic constituents with fixednegative charges, generating what are called “streaming potentials.”Studies of electrical phenomena in cartilage have demonstrated amechanical-electrical transduction mechanism that resembles thosedescribed in bone, appearing when cartilage is mechanically compressed,causing movement of fluid and electrolytes over the surface of fixednegative charges in the proteoglycans and collagen in the cartilagematrix. These streaming potentials serve a purpose in cartilage similarto that in bone, and, along with mechanical strain, lead to signaltransduction that is capable of stimulating chondrocyte synthesis ofmatrix components.

In contrast to direct currents, PEMFs are able to penetrate cellmembranes and either stimulate them or directly affect intracellularorganelles. As a result, the effect of PEMFs on extracellular matricesincludes increased synthesis of cartilage molecules, thereby enabling a“remodeling” of the knee joint.

FIG. 2 is a block diagram illustrating EMT² stimulation device 10 fortreating osteoarthritis in the knee according to one embodiment. Thisdevice embodiment 10 has a signal generator 12, power source 14, firststimulating means 16A, and second stimulating means 16B. Firststimulating means 16A is coupled to first output 18A of signal generator12 via first signal line 20A. Similarly, second stimulating means 16B iscoupled to second output 18B of signal generator 12 via second signalline 20B. In various embodiments, the first stimulating means 16A haseither or both of an electromagnetic stimulating means 26A and a thermalexchange component 28A and the second stimulating means 16B has eitheror both of an electromagnetic stimulating means 26B and a thermalexchange component 28B.

First and second signal lines 20A and 20B are configured to deliver thesignals generated by signal generator 12 to create the appropriatetherapeutic stimulation via first and second stimulating means 16A and16B. First and second signal lines 20A and 20B may be “wired,” such aswith coaxial cable. Alternatively, a “wireless” connection means, suchas Bluetooth, may be used. Although stimulation device 10 is shown ashaving two output ports 18A and 18B for simultaneously and independentlydelivering output signals (either the same or different signals) to twostimulating means 16A and 16B, one skilled in the art will appreciatethat the number of output ports and stimulating means may be variedwithout departing from the intended scope of the implementationsdisclosed herein. Thus, embodiments of device 10 that include any numberof stimulating means are contemplated. For example, in one alternativeembodiment, the device 10 can have one stimulating means.

Power source 14, which may be, for example, a lithium battery pack, isprovided for delivering a current input to signal generator 12. Whileshown in FIG. 2 as a remote unit, power source 14 may be incorporated aspart of or housed together with signal generator 12. Since theembodiments may be designed with low power requirements, power source 14may be one capable of providing an average power input of less thanabout 300 mW per session. As a result, power source 14 is generallysmall and lightweight. In an alternative embodiment, the device 10 hastwo power sources—one to supply power to the signal generator andanother to supply power to create the thermal exchange.

As shown in FIG. 2, signal generator 12 may include voltage regulator 22and microcontroller 24. Furthermore, first stimulating means 16A mayinclude first electromagnetic stimulating means 26A and first thermalexchange component 28A, while second stimulating means 16B may includesecond electromagnetic stimulating means 26B and second thermal exchangecomponent 28B. In one embodiment, the first and second electromagneticstimulating means 26A, 26B are first and second coils 26A, 26B. Voltageregulator 22 may be used to provide various required supply voltages tofirst and second electromagnetic stimulating means 26A and 26B. Firstand second electromagnetic stimulating means 26A and 26B may betriggered by microcontroller 24, which may be designed to generateaccurate pulses at a particular triggering and switching frequency.Output signals are delivered from microcontroller 24 to first and secondstimulating means 16A and 16B, each of which is individually responsiveto the signals to create a pulsed electromagnetic field.

As shown in FIG. 2, alternative embodiments of the device 10 may furtherinclude display 30 and monitoring means 32. Display 30 may be designedto display many different treatment parameters, including but notlimited to a treatment mode, a power level, and an amount of timeremaining in a treatment session.

Monitoring means 32 may be designed for monitoring one or more of theoutput conditions of stimulation device 10. In particular, monitoringmeans 32 may be configured to ensure that accurate treatment dosages aredelivered through first and second stimulating means 16A and 16B to thepatient's knee. One condition that may be monitored by monitoring means32 is the electromagnetic field generated by first and second coils 26Aand 26B. In particular, monitoring means 32 may include circuitry toboth detect the strength of the electromagnetic field and adjust thesignals delivered to the coils if the sensed field is not in accordancewith the desired treatment level. A second condition that may bemonitored by monitoring means 32 is tissue temperature generated byfirst and second thermal exchange component 28A and 28B. If, forexample, monitoring means 32 senses a tissue temperature that is out ofan acceptable range and poses a danger of injuring tissue around theknee, monitoring means 32 may communicate with the patient throughdisplay 30 to instruct removal of device 10 from the patient's knee.

For example, in one embodiment, monitoring means 32 may include a signaldetector coupled to first stimulating means 16A and/or secondstimulating means 16B for measuring the energy emission from first andsecond coils 26A and 26B. The signal detector may be designed so as totransmit a feedback signal to signal generator 12 for controlling theenergy output. The actual electromagnetic energy field, or treatmentdosage, that is transmitted from first and second stimulating means 16Aand 16B may be measured directly by embedding the signal strengthdetector within the stimulating means. The signal level measured by thesignal detector may then be sent to signal generator 12, where it may beused as a feedback control signal to control the output signals of thegenerator. If, at any time, monitoring means 32 detects a field strengthoutside of the desired range of the treatment mode, display 30 maydisplay an audible, visible, tactile, or other type of alarm to informthe patient and/or physician of a malfunction in the treatment mode.Furthermore, if the measured field strength is at or above a level thatposes a risk of danger, the feedback circuit of monitoring means 32 maystop the treatment to ensure that the patient is not harmed. As will beappreciated by one skilled in the art, monitoring means 32 mayalternatively or additionally include a temperature sensor andassociated feedback control to sense and control tissue temperaturearound the patient's knee.

As shown in FIG. 2, device 10 may be connected to a computer system 34to allow the physician to program treatment modes into microcontroller24. In this manner, the physician retains control over the type oftreatment that the patient receives since device 10 may be designed suchthat only the physician is able to access and modify the programmedtreatment modes. Through computer system 34, the physician may alsomonitor the treatment conditions to ensure that, for example, thecorrect field strength is being generated.

In order to make treatment with stimulation device 10 more convenientfor both the physician and the patient, telemetry means 36 may beincorporated into the device. In general, telemetry allows for theremote measurement and reporting of information of interest to a remotesystem or operator. In addition, telemetry allows for the remoteoperation and control of a device by allowing the operator to remotelysend instructions to or program the device.

With respect to stimulation device 10, telemetry means 36 enables thephysician to remotely monitor the treatment as well as modify thetreatment modes programmed into microcontroller 24. In this way, thephysician has the ability to control and prescribe treatment modeswithout the requirement of a face-to-face consultation with the patient,thus making treatment of osteoarthritis more convenient for both thepatient and the physician. In one embodiment, telemetry means 36 mayoperate using wireless communication, such as by utilizing a radiofrequency (RF) system to implement the data link between the device andremote system. However, telemetry means 36 may alternatively transferdata over other media, such as a telephone line, a computer network, orvia an optical link.

Now that certain embodiments of the EMT² stimulation device have beengenerally described in reference to the block diagram illustration ofFIG. 2, one exemplary embodiment of a stimulation device that may beworn by a patient for the treatment of osteoarthritis will be described.In particular, FIG. 3 illustrates a stimulation device 110, whichgenerally includes a knee cuff 111, a housing 131 in which a signalgenerator and a power source are positioned, a first stimulating means116A, a second stimulating means 116B, and a fastening means 117. Thehousing 131 can be positioned anywhere on the cuff 111. The device 110alternatively also has a display 130 that can display one or moretreatment parameters, such as the treatment mode or the amount oftreatment time remaining in a therapy session. In the embodimentdepicted in FIG. 3, the display 130 is located on the housing 131.Alternatively, the display 130 can be positioned in any location fromwhich the display is visible to the user during use. Stimulation device110 is a device for providing electromagnetic field stimulation andthermal therapy to a patient's body to promote healing. In particular,stimulation device 110 may provide pulsed electromagnetic fieldstimulation and thermal therapy (via first and second stimulating means116A and 116B) to a knee joint suffering from the effects ofosteoarthritis to promote healing of the knee. However, one skilled inthe art will appreciate that various device embodiments disclosed hereinmay be useful to provide electromagnetic field stimulation and thermaltherapy (EMT²) to various other locations on a patient's body to promotehealing or provide a therapeutic effect.

Knee cuff 111 includes main body portion 113, first set of strap members115A, and second set of strap members 115B. First set of strap members115A include first fastening members 117A, while second set of strapmembers 115B include second fastening members 117B. As will be discussedin the following paragraphs, first fastening members 117A are configuredto mate with second fastening members 117B in order to removably couplefirst set of strap members 115A to second set of strap members 115B andthus, to secure knee cuff 111 to the patient's knee.

FIGS. 4A and 4B illustrate stimulation device 110 secured to thepatient's knee, according to one embodiment. In particular, FIG. 4Aillustrates a front side of the patient's knee, while FIG. 4Billustrates a back side of the knee. Knee cuff 111 of stimulation device110 is wrapped around the knee such that first set of strap members 115Ahaving first fastening members 117A overlap with second set of strapmembers 115B having second fastening members 117B to secure the cuff atthe desired location on the knee. When properly secured to the knee,first stimulation means 116A is positioned at a lateral knee location,while second stimulating means 116B is positioned at a medial kneelocation. In one embodiment, first fastening members 117A and secondfastening members 117B form a hook-and-loop fastening means, such asthat commonly known as VELCRO®, wherein first fastening members 117A arethe “hook” portions and second fastening members 117B are the “loop”portions. However, other means of fastening may be used including, butnot limited to, buckles, snaps, and zippers. In alternate embodiments ofknee cuff 111, no fastening means is used. Instead, the fabric formingthe wrap is capable of being stretched and is able to hold itself inplace due to the elasticity of the wrap.

FIG. 5 is an exploded perspective view of stimulation device 110according to a further embodiment. As shown in FIG. 5, first stimulatingmeans 116A includes first coil 126A, first stimulating means holder125A, first stimulating means holder base plate 121A, first thermalexchange component 128A, and first stimulating means housing 119A. Firstcoil 126A of first stimulating means 116A is designed to be containedwithin the first stimulating means holder 125A. The first stimulatingmeans holder base plate 121A provides a base for the first stimulatingmeans holder 125A to attach to in order to be joined to the knee cuff bymeans of any one of such exemplary attachment mechanisms as, but notlimited to, an irreversible snap-fit hook mechanism, ultrasonic welding,or glue. In one embodiment, the first stimulating means holder baseplate 121A may be permanently attached to the knee cuff 111 by sewing,glue, or any known attachment means. First thermal exchange component128A is designed to be contained within first thermal stimulating meanshousing 119A. Housing 119A may then be enclosed on a back side by a thinplastic barrier 123A formed from a material such as Tyvek®. The thinbarrier 123A can be attached to the housing 119A by glue, heat seal, ora plastic snap-fit cover 118A. First thermal exchange component 119A isinsertable into first stimulating means holder 125A, which is coupled toknee cuff 111 as shown in the embodiment depicted in FIG. 3.

Although not shown in an exploded view like first stimulating means116A, second stimulating means 116B includes similar components in asimilar configuration. Thus, the discussion focuses on first stimulatingmeans 116A for purposes of example only, but applies equally to secondstimulating means 116B. As a result, second stimulating means 116Bincludes similar components having similar reference numerals.

The signal generator 112 depicted schematically in FIG. 5 includes avoltage regulator 122 and a microcontroller 124, which control thesignals transmitted through the wire harness 132 to first and secondcoils 126A and 126B to provide the pulsed electromagnetic field to theknee. The wire harness 132 is hidden within the different fabric layersof the knee cuff 111. Power source 114, which provides power to voltageregulator 122, is positioned in the same housing that contains thesignal generator means 112. However, as discussed above, power source114 may alternatively be positioned remotely from the signal generatormeans 112. In a further alternative embodiment, two power sources areprovided: one for the signal generator and one for the thermal exchangecomponent. In yet another embodiment, three power sources are provided:one for the signal generator and one for each of the thermal exchangecomponents. In one embodiment, the power sources for the thermalexchange components are single-use heating mixtures that provide energywhen exposed to air.

First and second coils 126A and 126B are either unipolar or bipolarelectromagnets that generate a magnetic field when electrical currentflows through them. The magnetic field is created by passing an electriccurrent through first and second coils 126A and 126B, which arepreferably formed from a long wire strand coiled around a core. The“pulsed” electromagnetic field may be created by programmingmicrocontroller 124 to turn the electromagnetic field on and off at arapid rate.

Although first and second thermal exchange components 128A and 128B arenot required components, incorporating them into first and secondstimulating means 116A and 116B, respectively, may provide beneficialtreatment results. In particular, when used in combination withelectromagnetic therapy, thermal therapy is helpful in treating theeffects of osteoarthritis and improving patient compliance. However, oneskilled in the art will appreciate that embodiments of stimulationdevice 110 that apply only thermal therapy, only electromagnetictherapy, or a combination of both therapies are possible. As a result,the stimulation devices described herein may be tailored to theparticular needs of different patients.

Heat is a natural remedy that may be used to both relieve pain andreduce discomfort. This is accomplished by stimulating the patient'sthermoreceptors which, in turn, aid in blocking the pain sensation fromreaching the brain by relaxing deep muscles to reduce tenderness andpain. In order to attain a therapeutic heat transfer effect includingincreases in tissue temperature, blood flow, muscle lengthening, andmetabolism, an intramuscular temperature of about 104 degrees F. (40degrees Celsius) must be reached.

Numerous types of heat sources may be utilized to provide beneficialheat therapy in accordance with various implementations. For example,first and second thermal exchange components 128A and 128B may bemulti-use cartridges that require the patient to ‘re-heat’ thecartridges before every use, such as by placing the cartridges in themicrowave. Alternatively, first and second thermal exchange components128A and 128B may be one-time use cartridges that are designed toprovide an irreversible exothermic reaction to provide a source of heatfor a specified amount of time. In one embodiment, first and secondthermal exchange components 128A and 128B are cartridges that containiron, carbon, sodium chloride, sodium thiosulfate, and water. When theCLLHW compound is exposed to air, it undergoes an exothermic reactionthat produces heat. In other embodiments, heat may be provided through:a resistive based heating source; selective insulation; or “warmth”radiated from the battery during operation. As will be appreciated byone skilled in the art, first and second thermal exchange components128A and 128B may be heat sources designed such that they deliver heattherapy for any designated period of time ranging from a few minutes tothe entire day. This designated period may or may not coincide with theelectromagnetic field duration. In addition, first and second thermalexchange components 128A and 128B may be pulsed such that the heattherapy is not constant.

In one embodiment, power source 114 is a lithium-polymer battery, whichmay be either a single-use battery or a rechargeable, multi-use battery.If power source 114 is a rechargeable type battery, stimulation device110 may be configured for attachment to a docking station for rechargingthe device. Alternatively, the docking station may be designed toreceive only power source 114, which may be made removable fromstimulation device 110. As one skilled in the art will appreciate,numerous other types of power sources may be used to provide therequisite power to stimulation device 110. For example, stimulationdevice 110 may be designed to create power from the patient's bodymovements. Alternatively, stimulation device 110 may be powered througha chemical reaction with heat being the by-product. In this case, theheat by-product may provide the heat therapy to the knee joint.

As shown in FIG. 5, stimulation device 110 further includes display 130for displaying one or more treatment parameters, such as the treatmentmode or the amount of treatment time remaining in a therapy session.Display 130 may utilize many different types of indicator means such as,for example, a light source, a heat-sensitive material that changescolor (as a function of elapsed time), a digital timer, or soundrepetition. In addition, display 130 may function together with amonitoring means in order to transmit an audio, visual, or tactile-typemessage to the patient in response to the monitoring means sensing, forexample, an electromagnetic field strength that is outside of thatdefined by the treatment mode. In this instance, display 130 is usefulto instruct the patient to remove the stimulation device or to call hisor her physician.

FIG. 6 is an enlarged illustration of the exploded perspective view ofFIG. 5, according to one embodiment. In this embodiment, the stimulatingmeans housings 119A, 119B as depicted in FIG. 5 are insertable,replaceable units that can be easily and quickly inserted into andremoved from the means holders 125A, 125B. In one embodiment, thestimulating means housings 119A, 119B have connections that, uponinsertion into the holders 125A, 125B, couple with connections in theholders 125A, 125B to supply power to the housings 119A, 119B.

FIG. 6 depicts one embodiment of a stimulation device 110 withinsertable stimulating means housings 119A, 119B. As shown in FIG. 6,the stimulation device 110 has a metal plate 140A in the stimulatingmeans housing 119A and a first pair of stimulating means holderspring-loaded metal contacts 142A. When the stimulation device 110 isassembled as shown in the embodiment of FIG. 3, the metal plate 140A onthe stimulating means housing 119A is used to make an electricalconnection with a pair of spring-loaded metal contacts 142A in the firststimulating means holder 125A. The protrusions 133A on the stimulatingmeans housing 119A can slide in and out of the grooves 134A on thestimulating means holder 125A and engage in the notches 135A to create areversible mechanical snap-in feature that allows for secure insertionand removal of the housing 119A to the stimulating means holder 125A. Inan alternative implementation, the metal plate 140A in the stimulatingmeans housing 119A makes contact with the first pair of stimulatingmeans holder magnets that are inserted into a first pair of magnetnotches in first stimulating means holder 125A for securing the housing119A to the first stimulating means holder 125A. In a furtheralternative, instead of a metal plate, the stimulation device 110 canhave a pair of stimulating means magnets and a corresponding pair ofstimulating means holder magnets.

The first pair of stimulating means holder spring-loaded metal contacts142A are coupled to a corresponding pair of signal lines (not shown) incommunication with signal generator 112. When first stimulating meanshousing 119A is positioned within first stimulating means holder 125A,the electrical connection between the metal plate 140A and thecorresponding first pair of stimulating means holder spring-loaded metalcontacts 142A creates a closed circuit that electrically couples firststimulating means 116A to signal generator 112. As a result, signalgenerator 112 is able to communicate with first stimulating means 116Ato deliver the prescribed treatment signals defined by the treatmentmode programmed into microcontroller 124.

The embodiment of stimulation device 110 illustrated in FIGS. 3-6 is atwo coil arrangement with one coil on either side of the knee forgenerating the PEMF therapy. In general, voltage regulator 122 is usedto provide a constant supply voltage to signal generator 112, and firstand second stimulating means 116A and 116B. Microcontroller 124 triggersfirst and second coils 126A and 126B, thereby generating accurate pulsesat a particular triggering and switching frequency defined by thedesignated treatment mode stored in the microcontroller. The triggeringfrequency is defined as the rate at which a set number of pulses occur.The switching frequency is the fundamental frequency of the individualpulses. Another parameter called the switching duty cycle is defined asthe ratio of the pulse width over the switching period. The voltage ofthe pulses is equivalent to the amplitude of the PEMF therapy.

The required penetration depth of the pulsed electromagnetic fieldgenerated by signal generator 112 and first and second stimulating means116A and 116B may vary depending upon, for example, the size of thepatient's knee region. However, for an adult patient, the penetrationdepth is generally in the range of about 1 cm to about 5 cm.Alternatively, the penetration depth is in the range of about 2 cm toabout 4 cm. In a further alternative, the penetration depth ranges fromabout 2 cm to about 2.5 cm. This “penetration depth” parameter isnecessary in order to estimate the magnetic field intensity needed toprovide the therapy, which ultimately determines the power requirementof power source 114.

In general, the magnetic field intensity generated by a coil is measuredin terms of Tesla (T) and has the following approximate relationshipwith current flowing through the coil:

$B = {{\frac{\mu_{0}{nIR}^{2}}{2\left( {R^{2} + x^{2}} \right)^{3/2}}I}\frac{2\; {B\left( {R^{2} + x^{2}} \right)}^{3/2}}{\mu_{0}{nR}^{2}}}$

where “B” is the magnetic field produced by the coil, “I” is the currentthrough the coil, “R” is the radius of the coil, and “x” is thepenetration depth of the PEMF.

According to one embodiment, the magnetic field strength B applied tothe target body part of the patient ranges from about 10 μT to about2,000 μT. Alternatively, the magnetic field strength B ranges from about20 μT to about 100 μT. In a further alternative, the magnetic fieldstrength B ranges from about 30 μT to about 50 μT. In yet anotheralternative, the magnetic field strength B is about 40 μT. According toone embodiment, the magnetic field produced by the coil is appliedperpendicular to the coil.

In one implementation, the magnetic field is applied into the knee for adistance ranging from about 1 cm to about 5 cm into the knee.Alternatively, the magnetic field is applied for a distance ranging fromabout 2 cm to about 4 cm into the knee. In a further alternative, themagnetic field is applied to a distance ranging from about 2 cm to about2.5 cm into the knee.

The coil, in accordance with one embodiment, has 20 turns of a 24 AWGwire around a core with a radius of about 2centimeters with a pulsedcurrent 712 mA. Alternatively, the coil has 65 turns of a 28 AWG wirearound a core with a radius of 1.5 cm with a pulsed current of 339 mA.

While a single-coil configuration is possible and within the intendedscope of this application, the two-coil configuration uses about 20times less power than the single-coil configuration because it requiresa significantly smaller amount of energy to penetrate both the lateraland medial side of the knee. Furthermore, embodiments having more thantwo coils are also contemplated.

In one embodiment, the PEMF therapy is applied for period ranging fromabout 30 minutes to about 4 hours. Alternatively, the PEMF therapy isapplied for a period ranging from about 1 hour to about 3 hours. In afurther alternative, the therapy is applied from about 1.5 to about 2.5hours. In yet another alternative, the therapy is applied for about 2hours. Further, the optimal treatment window may vary depending uponmany factors, including, but not limited to, the field intensityprovided to the knee, the severity of the osteoarthritis in the knee,and the physical dimensions of the knee.

According to one implementation, the triggering frequency ranges fromabout 1 Hz to about 100 Hz. Alternatively, the triggering frequencyranges from about 5 Hz to about 50 Hz. In a further alternative, thetriggering frequency ranges from about 10 Hz to about 20 Hz. In yetanother alternative, the triggering frequency is about 15 Hz.

In accordance with one embodiment, the switching frequency ranges fromabout 50 Hz to about 100 kHz. Alternatively, the switching frequencyranges from about 300 Hz to about 70 kHz. In a further alternative, theswitching frequency ranges from about 2 kHz to about 4 kHz. In yetanother alternative, the switching frequency is about 3 kHz.

In general, in order to achieve the optimal therapeutic effect with thePEMF, a triggering frequency in the range of about 15 Hz and a switchingfrequency in the range of about 3 kHz are desirable, although othertriggering and switching frequencies are also contemplated.

As one skilled in the art will appreciate based upon the abovedisclosure, stimulation device 110 does not require connection to anyexternal hardware while delivering the prescribed therapy. Thus,stimulation device 110 is portable, and is designed such that it may beworn by the patient during their normal daily activities withoutdiscomfort. Knee cuff 111 may be both ergonomically designed andcosmetically appealing to increase patient compliance with wearing thedevice.

First and second stimulating means 116A and 116B may be designed ascomplete or partial disposable units that may be discarded and replacedafter a predetermined number of treatments. For example, stimulatingmeans housing 119A, which may include first thermal exchange component128A and/or first coil 126A, may be removed from stimulation meansholder 125A and disposed of by the patient upon expiration. Optionally,display 130 may instruct the patient when the units have expired andrequire replacement. The disposability feature of first and secondstimulating means 116A and 116B may be advantageous because if one ormore of the stimulating means stops functioning properly, it is onlynecessary to replace those components and not the entire stimulationdevice.

Another exemplary embodiment of an EMT² stimulation device is depictedin FIG. 7. The device 200 shown in FIG. 7 has a PEMF generationcomponent 202 and a thermal exchange component 204. The PEMF generationcomponent 202 is positioned between a first exterior layer 206 and asecond exterior layer 208. According to one embodiment, the first layer206 has an adhesive component 210 on at least a portion of the side ofthe layer external to the device 200. The adhesive component 210 is anyknown adhesive that allows for attaching the device 200 to the patient'sskin.

In accordance with one implementation, the device 200 also has a powersource (not shown) positioned in an external casing 212 positioned onthe second layer 208. In a further embodiment, certain electroniccomponents can be positioned in the casing 212.

Alternatively, the device 200 has two power sources (not shown)—one forthe PEMF generation component 202 and one for the thermal exchangecomponent 204. Two different power sources can help to maximize batterylife. Alternatively, one power source is provided for both the PEMFgeneration component 202 and the thermal exchange component 204. In afurther embodiment, one power source is provided for the PEMF generationcomponent 202, and the thermal exchange component 204 in this embodimentrequires no power source, as explained in further detail below.According to one implementation, the single power source or both powersources are positioned in the external casing 212. Alternatively, thesingle power source or both power sources are positioned between thefirst layer 206 and the second layer 208. In a further alternative, onepower source is positioned in the external casing 212 and one powersource is positioned in between the first 206 and second 208 layers.

In one embodiment, one or both of the power sources are a single-use ordisposable power source. Alternatively, the one or more power sourcescan be reusable or permanent power sources. In a further alternative,the power source is any known power source for use with a PEMFstimulation device and/or a thermal exchange component.

In one embodiment, the device 200 is a single-use patch-like device.Alternatively, the device 200 is a reusable device. As shown, the device200 has a square shape. Alternatively, the device 200 can have acircular or round shape or any other known shape. For example, in oneembodiment, the device 200 may have any shape that maximizes attachmentto the patient's skin and patient comfort.

In this embodiment, the PEMF generation component 202 is a coilconfigured to generate the pulsed electromagnetic field. Alternatively,the PEMF generation component 202 can be any known component forgenerating a PEMF.

According to one implementation, the thermal exchange component 204 is aheat source such as, for example, a component having an exothermicchemical mixture. For example, the heat source in one embodiment is amixture containing iron powder, water, activated charcoal, and salt thatoxidizes in air to generate heat. One commercial example of such amixture can be found in hand warming products sold by HeatMax®, which islocated in Dalton, Ga. Another example of a heat source that can be usedwith the present embodiment is a mixture containing super-cooled sodiumacetate. Yet another example is a mixture containing calcium chloride ormagnesium sulfate and water. In a further alternative, the thermalexchange component can be any known component or device for generatingheat.

In accordance with one implementation in which the thermal exchangecomponent 204 is a heat source utilizing an exothermic chemical mixture,the component 204 does not require a power source. That is, the chemicalmixture generates the exothermic reaction without the need for anybattery or any other kind of power source.

Alternatively, the thermal exchange component 204 is a cooling sourcesuch as, for example, a component having an endothermic chemicalmixture. For example, the cooling source can be a mixture containingammonium nitrate and water. In a further alternative, the thermalexchange component 204 can be any known component for providing atemperature reduction.

In one implementation, the first and second exterior layers 206, 208 areflexible or pliable layers. The layer pliability or flexibility can,according to one embodiment, facilitate attachment of the device 200 tothe patient's skin. In one alternative embodiment, one or both of theexterior layers can be gas permeable. In a further alternative, one orboth of the exterior layers are permeable to oxygen. The layers 206, 208can consist of a biocompatible membrane such as, for example, theTegaderm™ and Medipore™ products available from 3M™ Company, located inSt. Paul, Minn.

According to one embodiment, the adhesive component 210 is ahypoallergenic adhesive. In a further alternative implementation inwhich one or both of the exterior layers 206, 208 are gas permeable, theadhesive component 210 is a porous adhesive that allows gas to passthrough the adhesive and the gas permeable layer.

It is understood that this device 200 can be used to treat any joint orany other body part that might benefit from treatment with PEMF andthermal exchange. In one embodiment, the target area is the knee. It isfurther understood that more than one device 200 could be used to treata target area. The device 200 can be used to relieve osteoarthritis painand increase range of motion.

One skilled in the art will appreciate that although the devices andmethods have been described in reference to only a few embodiments of astimulation device, these embodiments are provided for purposes ofexample and not limitation. Accordingly, numerous other embodiments arepossible and within the intended scope.

Other Examples

FIG. 8 illustrates generally an example of an active knee systemincluding a stimulation device 110, the stimulation device 110 includinga knee cuff 111 having a first layer 111A and a second layer 111B. Inthe example of FIG. 8, the active knee system includes a portable,battery operated, non-invasive shortwave diathermy medical device thatapplies electromagnetic energy for the treatment of medical conditionsusing means other than the generation of deep heat within body tissues(e.g., using athermal means).

In an example, the active knee system can be configured to deliver apulsed RF signal to a target tissue via inductive coupling withapplicator coils (e.g., a first coil 126A and a second coil 126B). Inthis example, the applicator coils are placed on either side of a knee(e.g., the medial and lateral areas of the knee joint) within the kneecuff 111 (e.g., between the first layer 111A and the second layer 111B).In other examples, the applicator coils can be placed in other locationsabout the knee cuff (e.g., depending on the desired target tissue) orone or more applicator coils can be placed in one or more locationswithin one or more other cuffs configured to be placed about one or moreother parts of the body.

In an example, separate RF signal generators can be located proximateeach applicator coil (e.g., within a stimulation means holder, proximatean applicator coil, or in certain examples, within the same sub-assemblyas the applicator coil) to significantly reduce potential RF signaldegradation in comparison to a system having multiple applicator coilsseparately routed, in some examples, substantially large distances, to asingle RF signal generator. In other examples, separate RF signalgenerators can be assigned to a first group of applicator coils locatedin closer proximity than a second group of applicator coils.

In certain examples, one or more of the RF signal generators or theapplicator coils can be controlled by a single microcontroller containedwithin a separate housing (e.g., a housing 131) removable from the kneecuff 111 (or one or more other cuff). The microcontroller can controlthe RF signal generators (e.g., on-state, off-state, etc.) using alow-speed power line. The combination of the RF signal generatorslocated proximate the applicator coils and the separate microcontrollercan allow complete modularization of the system (e.g., the one or moreRF signal generators or applicator coils can be placed independentlyfrom the microcontroller).

The stimulation device 110 can include one or more disposable,single-use, air activated pods that provide heat or cold to a targettissue. In an example, the one or more pods can be snapped or otherwiseattached into medial and lateral slots or holders on the knee cuff 111.In various examples, treatment (e.g., PEMF therapy, or one or more ofthermal therapy or electromagnetic therapy) can occur through dressings,clothing, casts, compression garments, supports, or one or more otherbarrier between the knee cuff 111 and the target tissue. Further, incertain examples, the pods (separately or in combination) can act as anactivator switch that enables or turns on one or more portion of thePEMF therapy.

In an example, the PEMF therapy can include one or more of the followingparameters: 1 W peak generator power; 4 mW average generator power; 3 Vgenerator voltage; a voltage standing wave ration of approximately 1; 10mA current; 27.12 MHz carrier frequency; 2 msec burst duration (e.g., 2msec burst on, and 498 msec burst off); 2 Hz burst frequency; 50 Ohmstandard load; etc. In other examples, the PEMF therapy can include oneor more other parameters.

Although the example of FIG. 8 illustrates generally an active kneesystem, one or more other systems configured to provide therapy to oneor more other target areas are consistent with the teachings herein,such as an active ankle system, an active wrist system, etc.

Active Ankle System

FIG. 9 illustrates generally an example of an active ankle systemincluding a stimulation device 110, the stimulation device 110 includingan ankle cuff 151 configured to be worn around an ankle, first andsecond stimulating means 116A, 116B configured to provide therapy to theankle, and a housing 131 configured to store a microcontroller tocontrol at least a portion of at least one of the first or secondstimulating means 116A, 116B. In an example, the ankle cuff 151 caninclude fasteners, in this example, first and second straps 152, 153configured to cross over the front of the ankle and securely fasten theankle cuff 151 to the ankle. In an example, the fasteners can includehook and loop fasteners, or one or more other type of fastener.

The active ankle system can be configured to deliver PEMF therapy (e.g.,a pulsed RF signal) to a target tissue using one or more applicatorcoils (e.g., first and second coils), as well as thermal therapy (e.g.,heat therapy) using one or more disposable, single-use air activatedpods, to a target area of the ankle. In an example, the first or secondstimulating means 116A, 116B can include at least one of an applicatorcoil or a thermal pod. In an example, the PEMF or thermal therapies canbe provided near the tibiotalar and talocalcaneal joints of the ankle,which are generally the most common places for arthritis in the ankle tooccur. By positioning the applicator coils or the thermal pods at ornear the tibiotalar and talocalcaneal joints of the ankle, treatment ofboth the commonly injured (e.g., when an ankle is rolled or sprained)posterior and anterior talo-fibular ligaments is possible.

In other examples, the PEMF or thermal therapies can be used to reducepost-surgical pain and edema in the ankle, as well as provide one ormore other therapeutic benefits. Using the unique wrap designillustrated in FIG. 9, the ankle cuff 151 can be worn on either the leftor right ankle and still provide therapy to the target locations of theankle without producing different active ankle systems for each side.Further, the applicator coils or the thermal pods can be placed in oneor more other locations about the ankle cuff 151 due to the modulardesign of the system, such as described above.

Active Back System

FIG. 10 illustrates generally an example of an active back systemincluding a stimulation device 110, the stimulation device 110 includinga back wrap 161 configured to be worn around a back, stimulating means(e.g., first, second, third, and fourth stimulating means 116A, 116B,116C, 116D, respectively) configured to provide therapy to the back, anda housing 131 configured to store a microcontroller configured tocontrol at least a portion of at least one of the first, second, third,or fourth stimulating means 116A, 116B, 116C, 116D. In an example, theback wrap 161 can be positioned in place securely about the back usingfasteners, such as hook and loop fasteners located at opposite ends ofthe back wrap 161.

In an example, the active back system can be configured to deliver PEMFtherapy (e.g., a pulsed RF signal) to a target tissue using one or moreapplicator coils (e.g., first and second applicator coils, or any othernumber of applicator coils), as well as thermal therapy (e.g., heattherapy) using one or more disposable, single-use air activated pods, toa target area of the back. In certain examples, the first through fourthstimulating means 116A, 116B, 116C, 116D, can include at least one of anapplicator coil or a thermal pod. In an example, the PEMF or thermaltherapies can be provided on one or more sides of the spine, in one ormore areas of pain due to various reasons (e.g., surgery, arthritis,poor posture, etc.), such as the lumbar region of the back.

In an example, to reduce cost, but still provide therapy to the subject,a sub-set of stimulating means can include both the applicator coil andthe thermal pod, while others include only a thermal pod (e.g., thelower stimulating means including applicator coils and thermal pods, andthe upper stimulating means including only thermal pods, etc.). Further,the applicator coils or the thermal pods can be placed in one or moreother locations about the back wrap 161 due to the modular design of thesystem, such as described above.

Active Elbow System

FIG. 11 illustrates generally an example of an active elbow systemincluding a stimulation device 110, the stimulation device 110 includingan elbow cuff 171 configured to be worn around an elbow, first andsecond stimulating means 116A, 116B configured to provide therapy to theelbow, and a housing 131 configured to store a microcontrollerconfigured to control at least a portion of at least one of the first orsecond stimulating means 116A, 116B. In an example, the elbow cuff 171can be worn around the elbow, secured in place by fasteners (e.g., hookand loop fasteners located at ends of the elbow cuff 171) in a similarfashion as the active knee system is secured around the knee.

In an example, the first or second stimulating means 116A, 116B caninclude at least one of an applicator coil or a thermal pod. In anexample, the PEMF and thermal therapies can be provided near the medialand lateral sides of the elbow, in certain examples, providing treatmentover the lateral epicondyle to treat one or more injuries or condition,such as tennis elbow, etc.

In other examples, the PEMF and thermal therapies can be used to reducepost-surgical pain and edema in the elbow, as well as provide one ormore other therapeutic benefits. Using the unique wrap designillustrated in FIG. 11, the elbow cuff 171 can be worn on either theleft or right elbow and still provide therapy to the target locations ofthe elbow without producing different active elbow systems for eachside. Further, the applicator coils or the thermal pods can be placed inone or more other locations about the elbow cuff 171 due to the modulardesign of the system, such as described above.

Active Wrist System

FIG. 12 illustrates generally an example of an active wrist systemincluding a stimulation device 110, the stimulation device 110 includinga wrist cuff 181 configured to be worn around a wrist, first and secondstimulating means 116A, 116B configured to provide therapy to the wrist,and a housing 131 configured to store a microcontroller configured tocontrol at least a portion of at least one of the first or secondstimulating means 116A, 116B. In an example, the wrist cuff 181 can beworn by placing the thumb through the hole in the wrist cuff 181 andwrapping the wrist cuff 181 around the wrist. In an example, the wristcuff 181 can include fasteners, in this example, first and second straps182, 183. In an example, the fasteners can include hook and loopfasteners, or one or more other type of fastener.

In an example, the first or second stimulating means 116A, 116B caninclude at least one of an applicator coil or a thermal pod. In anexample, the PEMF and thermal therapies can be provided near the medialand lateral areas of the wrist, in certain examples, providing treatmentat or near the basal joint, a common location of arthritis. Further, bypositioning the applicator coils or the thermal pods at or near thebasal joint, treatment over the two collateral ligaments in the wrist ispossible.

In other examples, the PEMF or thermal therapies can be used to reducepost-surgical pain and edema in the wrist, as well as provide one ormore other therapeutic benefits. Using the unique wrap designillustrated in FIG. 12, the wrist cuff 181 can be worn on either theleft or right wrist and still provide therapy to the target locations ofthe wrist without producing different active wrist systems for eachside. Further, the applicator coils or the thermal pods can be placed inone or more other locations about the wrist cuff 181 due to the modulardesign of the system, such as described above.

FIG. 13 illustrates generally an example of an active wrist systemincluding a stimulation device 110, the stimulation device 110 includinga wrist cuff 191 configured to be worn around a wrist, first and secondstimulating means 116A, 116B configured to provide therapy to the wrist,and a housing 131 configured to store a microcontroller configured tocontrol at least a portion of at least one of the first or secondstimulating means 116A, 116B. In this example, the thumb can be pushedthrough the appropriate thumb hole and first and second straps 192, 193can be adjusted to secure the wrist cuff 191 in place using fasteners,such as hook and loop fasteners, or one or more other fasteners. In anexample, the wrist cuff 191 can secure the stimulation first and secondstimulating means 116A, 116B over the center of the wrist, allowing thetherapy to penetrate deep within the wrist.

In other examples, the PEMF or thermal therapies can be used to reducepost-surgical pain and edema in the wrist, as well as provide one ormore other therapeutic benefits. Using the unique wrap designillustrated in FIG. 13, the wrist cuff 191 can be worn on either theleft or right wrist and still provide therapy to the target locations ofthe wrist without producing different active wrist systems for eachside. Further, the applicator coils or the thermal pods can be placed inone or more other locations about the wrist cuff 191 due to the modulardesign of the system, such as described above.

Additional Notes

The above detailed description includes references to the accompanyingdrawings, which form a part of the detailed description. The drawingsshow, by way of illustration, specific embodiments in which theinvention can be practiced. These embodiments are also referred toherein as “examples.” Such examples can include elements in addition tothose shown or described. However, the present inventors alsocontemplate examples in which only those elements shown or described areprovided. Moreover, the present inventors also contemplate examplesusing any combination or permutation of those elements shown ordescribed (or one or more aspects thereof), either with respect to aparticular example (or one or more aspects thereof), or with respect toother examples (or one or more aspects thereof) shown or describedherein.

All publications, patents, and patent documents referred to in thisdocument are incorporated by reference herein in their entirety, asthough individually incorporated by reference. In the event ofinconsistent usages between this document and those documents soincorporated by reference, the usage in the incorporated reference(s)should be considered supplementary to that of this document; forirreconcilable inconsistencies, the usage in this document controls.

In this document, the terms “a” or “an” are used, as is common in patentdocuments, to include one or more than one, independent of any otherinstances or usages of “at least one” or “one or more.” In thisdocument, the term “or” is used to refer to a nonexclusive or, such that“A or B” includes “A but not B,” “B but not A,” and “A and B,” unlessotherwise indicated. In the appended claims, the terms “including” and“in which” are used as the plain-English equivalents of the respectiveterms “comprising” and “wherein.” Also, in the following claims, theterms “including” and “comprising” are open-ended, that is, a system,device, article, or process that includes elements in addition to thoselisted after such a term in a claim are still deemed to fall within thescope of that claim. Moreover, in the following claims, the terms“first,” “second,” and “third,” etc. are used merely as labels, and arenot intended to impose numerical requirements on their objects.

Method examples described herein can be machine or computer-implementedat least in part. Some examples can include a computer-readable mediumor machine-readable medium encoded with instructions operable toconfigure an electronic device to perform methods as described in theabove examples. An implementation of such methods can include code, suchas microcode, assembly language code, a higher-level language code, orthe like. Such code can include computer readable instructions forperforming various methods. The code may form portions of computerprogram products. Further, the code can be tangibly stored on one ormore volatile or non-volatile tangible computer-readable media, such asduring execution or at other times. Examples of these tangiblecomputer-readable media can include, but are not limited to, hard disks,removable magnetic disks, removable optical disks (e.g., compact disksand digital video disks), magnetic cassettes, memory cards or sticks,random access memories (RAMs), read only memories (ROMs), and the like.

The above description is intended to be illustrative, and notrestrictive. For example, the above-described examples (or one or moreaspects thereof) may be used in combination with each other. Otherembodiments can be used, such as by one of ordinary skill in the artupon reviewing the above description. The Abstract is provided to complywith 37 C.F.R. §1.72(b), to allow the reader to quickly ascertain thenature of the technical disclosure. It is submitted with theunderstanding that it will not be used to interpret or limit the scopeor meaning of the claims. Also, in the above Detailed Description,various features may be grouped together to streamline the disclosure.This should not be interpreted as intending that an unclaimed disclosedfeature is essential to any claim. Rather, inventive subject matter maylie in less than all features of a particular disclosed embodiment.Thus, the following claims are hereby incorporated into the DetailedDescription, with each claim standing on its own as a separateembodiment, and it is contemplated that such embodiments can be combinedwith each other in various combinations or permutations. The scope ofthe invention should be determined with reference to the appendedclaims, along with the full scope of equivalents to which such claimsare entitled.

What is claimed is:
 1. A system comprising: a disposable housingincluding a single-use thermal exchange component, the disposablehousing configured to be mechanically, removably coupled to a receptacleon a cuff positionable around a joint; and wherein the single-usethermal exchange component is configured to provide temperature-basedtherapy to the joint.